To assess safety and effectiveness of Sitagliptin, Glimepiride, and Metformin for diabetes patients in India.
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2024/03/064004
- Lead Sponsor
- Torrent Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Male or Female patients 18 to 65 years. Patients uncontrolled on dual therapy (Glimepiride + Metformin) or (Sitagliptin + Metformin) with HbA1c more than 7.5 & less than 8.5 %. Treatment-naïve with HbA1c more than 7.0 & less than 9.0%. Patients with FBG more than 126 mg/dl & PPG more than 200 mg/dl. Patients not taking any other OAD drugs. Patient willing to enroll for the study.
History of Type 1 diabetes.
Patients were treated with insulin within 8 weeks of screening.
Patients with renal dysfunction (crcl less than 60 ml/min) or proteinuria.
History of hypersensitivity.
Intolerance to the use of Sitagliptin, Glimepiride or Metformin.
Pregnant and lactating women.
Patients with Congestive Heart Failure, Unstable angina or ACS within past 6 months.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in HbA1c from baseline to 12 ± 1 weeks of treatment. <br/ ><br>Mean change in FBG and 1 & 2-h PPG levels from baseline to 4 ± 1 weeks and 12 ± 1 weeks followup. <br/ ><br>Mean change in weight after 12 ± 1 weeks of treatment from baseline. <br/ ><br>Drug-Dose utilization pattern.Timepoint: From baseline to 4 ± 1 weeks and 12 ± 1 weeks followup.
- Secondary Outcome Measures
Name Time Method Treatment adherence and compliance. <br/ ><br>Safety assessment and tolerability. <br/ ><br>Physician’s Global Assessment for improvement and user experience.Timepoint: From baseline to 4 ± 1 weeks and 12 ± 1 weeks followup.